Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04428658 |
| Other study ID # |
1616262 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2022 |
| Est. completion date |
August 1, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will test the hypothesis that supplemental synchronous video visits and
supplemental asynchronous remote monitoring can each significantly improve glycemic control
for pediatric patients with uncontrolled type 1 diabetes over a 6 month period, and will
compare health outcomes and patient-centered outcomes between these two intervention arms and
a control arm receiving usual care.
Description:
Design: Randomized, controlled trial of two different telehealth modalities as supplements to
usual diabetes care over a six-month period for pediatric patients with T1D and suboptimal
glycemic control.
Recruitment: Patients will be recruited either: 1) during regularly scheduled in-person
visits to the University of California, Davis (UCD) Pediatric Diabetes Clinic, or 2) via
phone for patients receiving telehealth rather than in-person care from a UCD Pediatric
Diabetes Clinic provider during the enrollment period. Inclusion criteria will be 1) age 5-18
years, 2) diagnosis of type 1 diabetes with a duration of >12 months, 3) suboptimal glycemic
control at time of enrollment, defined as a hemoglobin A1c (HbA1c) level > 8% (64 mmol/mol)
or a 14-day glucose management index (GMI) of >8% from continuous glucose monitoring (CGM)
data or 14-day average blood glucose of >200 mg/dl in the preceding month, 4) intention to
receive diabetes care at the UCD Pediatric Diabetes Clinic during the following year, 5)
access to the internet via a device with video and audio capability, and 6) ability to
connect the patient's home blood glucose meter or CGM device - as well as insulin pump, if
applicable - to an internet-capable device via Bluetooth or physical cable. Patients will be
excluded from participation if their home addresses are not in California, due to current
physician licensing restrictions that apply to inter-state home-to-clinic telemedicine
services. Written informed consent and assent will be obtained from participants and their
parents/guardians according to IRB regulations.
Test-Run, Randomization, and Baseline Data Collection: Prior to randomized allocation, each
patient enrolled in the study will complete a test-run of remote data-sharing and a
home-to-clinic video encounter with research staff to resolve any technical issues. These
procedures will help to ensure that patients' and their families' use of the necessary
programs and follow-through with scheduled tasks is successful. In my pilot study of
home-based video visits, 23% of enrolled patients failed to complete their first video
visits, effectively withdrawing from the study before receiving any of the intervention. This
test-run is designed to minimize similar attrition after randomization during the randomized
trial. Participants who successfully complete their test-run will be allocated 1:1:1 to usual
care, supplemental synchronous telehealth visits, or supplemental asynchronous remote
monitoring via a computer-generated, permuted block randomization scheme with variable block
sizes. The allocation schedule will be produced by a study statistician. Allocation
concealment will be achieved by using enumerated opaque envelopes (or a functional
equivalent) to prevent participant assignments being revealed to research staff prematurely.
After randomization, all participants will be asked to provide several types of baseline
data, including a HbA1c level - measured via home collection kit - and completion of several
validated survey instruments to assess patient-centered outcomes such as diabetes-related
distress and self-efficacy.
Synchronous Telehealth Arm: Participants in the synchronous telehealth arm will receive
home-based video visits with a pediatric endocrinologist every month for a duration of six
months. Video visits will be conducted using a HIPAA-compliant video conferencing platform. A
single pediatric endocrinologist will conduct all video visits, eliminating any
inter-provider variability in clinical approach. One day prior to scheduled video visits the
participants will receive reminders to upload data from their diabetes devices using secure
internet platforms that are compatible with their home computers, tablets, or mobile phones.
The research team will assist with initial setup of these platforms, and provide support for
any technical issues during the study. Each video visit will include discussion of interval
health events and patient or family concerns, review of shared glucose data and insulin dose
information, and provision of recommendations by the physician. This content is equivalent to
the physician portion of in-person diabetes clinic visits, except that a detailed physical
exam cannot be performed.
Asynchronous Remote Monitoring Arm: Participants in the remote monitoring arm will receive
monthly outreach from a pediatric endocrinologist based on the physician's asynchronous
review of remotely shared data from their diabetes devices (blood glucose monitors, CGM
devices, and/or insulin pumps) for a duration of six months. Recommendations from the
endocrinologist will be delivered to the parent/guardian for participants <18 years of age
and will also be sent to the pediatric participant if they have a phone or messaging account
and the parent/guardian consents to this contact. The recommendations provided may include
but will not be limited to advice about insulin dose changes, adjustments to insulin pump
settings, and discussion of strategies for diabetes-related behaviors and family
communication. In cases where glucose data suggests that glycemic targets are being met and
no adjustments are needed, the endocrinologist will provide feedback to this effect.
Participants' diabetes data will be shared with the research team via one or more secure
platforms that are selected based on the participant's specific device(s) and method of
uploading to the cloud (e.g., mobile versus computer with WiFi connection). In most cases,
the data will continue to share passively once the necessary link is established, but in some
cases monthly action may be needed by the participants. For this reason, the research team
will not only facilitate the initial setup of data-sharing but will also monitor on a monthly
basis for gaps in data and provide reminders, outreach, and assistance to participants as
needed to ensure data sharing continues.
Usual Care (Control) Arm: Participants in this arm will receive the same initial assistance
with setting up secure platforms for diabetes data-sharing but will not be scheduled to
receive monthly video visits or asynchronous messages with recommendations based on remote
monitoring. They will receive usual care at the UCD Pediatric Diabetes Clinic, which
typically includes at least quarterly in-person and/or telehealth visits, as well as the
option to share data with the diabetes clinic team at any point between visits and contact
providers for feedback or assistance as needed. It is possible that the assistance with
establishing data-sharing at time of enrollment will increase control participants'
engagement with diabetes self-care and/or their likelihood to contact the clinic team for
help. However, this is a strength of the study design because it will reduce any difference
in outcomes between groups that are due to these factors and will help isolate the effects of
the telehealth interventions themselves.
Post-Study Data Collection:
After completion of the six-month study period, all participants will be asked again to
provide a HbA1c value via a mail-in home kit, and to complete the same survey instruments
about patient-centered outcomes (diabetes-related distress and self-efficacy) that were
assessed at baseline, as well as to report any incidents of severe hypoglycemia (defined as
involving loss of consciousness, seizure, or need for emergency glucagon administration)
during the study period for safety monitoring purposes. In addition, participants in the two
intervention arms will be surveyed regarding the perceived burdens and benefits of the
intervention they received, including estimated time investment and technical problems
encountered - see manuscripts from the pilot study for details about these survey questions.
Data Collection and Study Variables:
1. Patient characteristics: Demographic information will be extracted from participants'
medical records at the time of enrollment including age, sex, race, ethnicity,
insurance, and home address (for calculation of geographic distance between home and
clinic).
2. Healthcare utilization: Dates of encounters of the following types will be extracted
from participants' medical records for the 6 months prior to and 6 months during study
participation: diabetes clinic visits (in-person and telehealth), ED visits, and
hospitalizations. Participants' use of diabetes technology - including insulin pumps and
CGMs - will also be extracted from the medical record at enrollment and at study
completion. In addition, the provider time spent to deliver the telehealth intervention
each month will be recorded for participants in the intervention arms in order to
facilitate analysis of provider time as a secondary outcome and/or an effect modifier
for the primary outcome. Categories of discussion - e.g., insulin dose adjustments,
diabetes skills/behaviors, diabetes technology use - will also be recorded each month
for participants in the intervention arms, along with the provider's assessment of
whether all, some, or none of the prior month's recommendations were implemented. This
data will assist with secondary analysis of what and when various types of T1D
management advice are most utilized by the participant cohort.
3. Patient experience: Responses to surveys administered to all participants will be
collected at baseline and at study completion. In addition, responses to the final
survey about perceived burdens and benefits of the interventions will be collected at
study completion from participants in the two intervention arms. Survey responses for
all study arms will be presented and evaluated qualitatively to gain insight into
patient experience.
4. Glycemic control: HbA1c values will be collected via home kits from all participants at
baseline and again at study completion. The primary outcome will be change in HbA1c from
baseline to study completion. All HbA1c values measured as >14% will be treated as
14.5%. This "trimming" of higher outlying values will tend to underestimate any
improvement in HbA1c during the study, so should not introduce type 1 error.
